Recall Z-0078-2023— Olympus Corporation of the Americas

Name: FDA recall Z-0078-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-16

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2022-09-16. It names one FDA 510(k) clearance: K171440. Product: Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.. Reason: Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of collection canisters which were not designed for use with the VC-10, which can lead to serious injuries as it does not fit properly with the VC-10..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2022-09-16
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K171440 — Berkeley VC-10 Vacuum Curettage SystemGyrus Acmi·cleared 2017-09-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.

Reason for recall

Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of collection canisters which were not designed for use with the VC-10, which can lead to serious injuries as it does not fit properly with the VC-10.

Data sourced from openFDA. This site is unofficial and independent of the FDA.